Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic
FDA device recall Z-2177-2014 · posted 2014-08-10 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- Reason for recall
- An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.
- Action taken
- Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 589 systems
- Distribution
- Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Nether
- Date initiated
- 2014-07-09
- Date posted
- 2014-08-10
- Date terminated
- 2017-05-12
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (K051258) | Eastman Kodak Company | 2005-06-01 |